Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1

Learn more about:
Related Clinical Trial
Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1 NF-1, Nutraceutical Intervention HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to Developing Biomarkers of Plexiform Tumor Burden in Patients With Neurofibromatosis-Type 1 Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1 Reliability of Functional Outcome Measures in Neurofibromatosis 1: Test- Retest Molecular Aspects of Preimplantation Genetic Diagnosis for NF1 Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1 Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults With Neurofibromatosis Type 1 Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas Systematically Assessing Changes in Plexiform Neurofibroma Related Disfigurement From Photographs of Subjects With Neurofibromatosis Type 1 on a Phase 2 Clinical Trial Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1 Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1 Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN) Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial Antioxidant Therapy With N-acetylcysteine for Children With Neurofibromatosis Type 1 Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1 A Long-term Study of NPC-12G Gel in Neurofibromatosis Type I NFX-179 Topical Gel Treatment in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas Medical Treatment of “High-Risk” Neurofibromas Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1 Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (PNs) Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform Neurofibromas Treatment of NF1-related Plexiform Neurofibroma With Trametinib Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients R115777 to Treat Children With Neurofibromatosis Type 1 and Progressive Plexiform Neurofibromas Use of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas Pirfenidone in Children and Young Adults With Neurofibromatosis Type I and Progressive Plexiform Neurofibromas Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas Ranibizumab for Neurofibromas Associated With Neurofibromatosis 1 AZD2171 in Treating Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma and/or Neurofibroma Near the Spine MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Study of Sutent®/Sunitinib (SU11248) in Subjects With NF-1 Plexiform Neurofibromas Neurofibromatosis Type 1 Brain Tumor Genetic Risk Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas Adaptation and Quality of Life Among Adults With Neurofibromatosis Type I Reliability of Functional Outcome Measures in Neurofibromatosis 1 Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults Medication Adherence in Children, Adolescents and Adults With Neurofibromatosis Type 1 (NF1) on Clinical Treatment Trials Targeting the Mechanisms Underlying Cutaneous Neurofibroma Formation in NF1: A Clinical Translational Approach. Sorafenib to Treat Children and Young Adults With Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST) Quality of Friendships in Children With Neurofibromatosis Study of Disease Severity in Adults With Neurofibromatosis Type 1 (NF1) MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas Interventions for Reading Disabilities in NF1 Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1 Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain Neurobiology and Treatment of Reading Disability in NF-1 From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1 Vitamin D Supplementation for Adults With Neurofibromatosis Type 1 (NF1) Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1 Analysis of Plasma for Diagnosis and Follow-up of Neurofibromatosis Type 1 Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms MicroRNAs in Patients With Neurofibromatosis Type 1 Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas Stem Cells in NF1 Patients With Tumors of the Central Nervous System Function of the Pigment Epithelium in Patients With Type 1 Neurofibromatosis NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1) Internet Support Group for Parents of a Child With Neurofibromatosis Type 1 Reading Disability in Children With NF1 Multi-center Project: Spinal Abnormalities in Neurofibromatosis Type1 (NF1) Patients Functional Imaging and Reading Deficit in Children With NF1 Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With NF1 Effect of Lamotrigine on Cognition in NF1 A Phase II Study of the mTOR Inhibitor Sirolimus in Neurofibromatosis Type 1 Related Plexiform Neurofibromas A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1 Neurofibromatosis Type 1 (NF1) and Tibial Dysplasia Non-invasive Stimulation in Neurofibromatosis Type 1 Modifying Genes in Neurofibromatosis 1 Natural History and Biology of Skin Neurofibromas in Neurofibromatosis Type 1 Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1 Spinal Abnormalities in Neurofibromatosis Type 1 (NF1) Neurofibromatosis Type 1 Patient Registry Frameshift Peptides of Children With NF1 Prevalence of Constitutional Mismatch-repair Deficiency Among Suspected Neurofibromatosis Type 1/Legius Syndrome Children Without a Malignancy and Without a NF1 or SPRED1 Mutation How Neurofibromatosis Type 1 (NF1) Affects Schoolwork and Self-Esteem

Brief Title

Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1

Official Title

Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1

Brief Summary

      This study has two primary objectives. The first is to determine if it is feasible and
      reliable for children and families with a diagnosis of Neurofibromatosis Type 1 (NF1) to use
      of blood pressure (BP) monitor at home.

      The second is to determine if there is a difference between a child's measured home BP using
      standard instructions or using a clinical hypnosis script. This will be determined by a
      randomised control trial design.

      Standard and hypnosis Home BP will be compared to the gold standard measurement of BP
      measured by a trained health care professional in clinic.

      Children who participate will complete a clinic-based BP with a health care professional,
      then will be randomised into either the standard home BP measurement or using a hypnosis
      script prior to BP measurement.
    

Detailed Description

      Neurofibromatosis Type 1 (NF1) is a rare autosomal dominate genetic disorder that affects an
      estimated that 1 in 2500 people or 10000 Australians. NF1 affects multiple systems throughout
      the body. The prevalence of hypertension(HTN) in children and adolescents in the general
      population is approximately 3.5%. Children and adolescents with a diagnosis of NF1 have an
      increased incidence of HTN, and has been documented as high as 6.1% to 12%. This is two times
      higher than the general population.

      Clinical adherence to the recommendation of recording annual blood pressure on patients has
      not been audited. The anecdotal experience of the authors is that most children do not have
      annual blood pressure (BP) measurements. With the increased uptake of telehealth following
      the COVID-19 pandemic, children and families may not be reviewed in person for significant
      periods of time as they prefer consultations over telehealth. As a result, children may miss
      having their annual blood pressure measured. As a young people with a diagnosis of NF1 have
      twice the risk of HTN, annual BP measurement is essential.

      The American Academy Paediatrics guideline outlines the best practice for BP measurement to
      ensure true BP reading: The child should be seated in a quiet room for 3-5 minutes before
      measurement, with back supported and feet uncrossed on the floor. The blood pressure should
      be measured on the right arm, using the correct sized cuff. This should be completed by a
      trained clinician. As part of this study, all participants will have a manual
      sphygmomanometer in clinic-based BP taken on day of recruitment.

      One of the primary objectives of this study is to determine if is feasible to use home blood
      pressure monitoring to screen children with NF1 for hypertension.

      Clinical Hypnosis is used as a non-pharmacological technique for reducing procedural anxiety,
      distress and discomfort with patients. Hypnosis scripts have been successfully used as
      non-pharmacological adjuncts to reduce pain and anxiety in adult patients undergoing
      interventional radiological procedures, demonstrating that the benefits of hypnosis
      techniques can be accessible to patients with little or no training or preparation.
      Furthermore, healthcare workers who are not experts in hypnosis can be trained to deliver
      scripts effectively.

      If a hypnosis script used while taking home blood pressure readings allows for a calm child
      and an equivalent clinic BP measure, hypnosis script and home BP monitoring could have
      greater application across the Royal Children's Hospital.

      Therefore the second aim of the study is to see if there is a difference in a child's BP
      measurements comparing a standard home BP measurement or utilising a calming hypnosis script
      prior to home BP measurement. This will be compared to the gold standard clinic-based BP
      measurement completed by a trained professional. The child's self-reported level of anxiety
      using the Children's Anxiety Meter Scale (CAM-S) will be measured after every BP measurement.
      In addition, family's perceptions of the process of home BP monitoring will also be
      collected.
    


Study Type

Interventional


Primary Outcome

Day 1. Clinic-based manual sphygmomanometer blood pressure measurement

Secondary Outcome

 Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)

Condition

Hypertension

Intervention

Group 1. Standard Home Blood Pressure Measurement

Study Arms / Comparison Groups

 Group 1: Standard Blood Pressure measurement at home
Description:  Standard home blood pressure measurement at home

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

54

Start Date

June 2022

Completion Date

March 30, 2023

Primary Completion Date

August 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Is between the ages of 5 and 18 years old at enrolment.

          -  Has a diagnosis of neurofibromatosis type 1(NF1), confirmed by a physician, and
             usually attends the NF clinic at The Royal Children's Hospital, Melbourne, Australia
             (RCH). Including children with known kidney and cardiac disease.

          -  Primary residence and residential postal address in Victoria.

          -  The child can sit quietly for 10-15 minutes at home to complete a blood pressure
             assessment.

          -  Provide a signed and dated participant and/or parent guardian information and consent
             form and or has a legally acceptable representative capable of understanding the
             informed consent document and providing consent on the participant's behalf.

          -  For inclusive diverse study group, Parent/caregiver who require an interpreter can be
             enrolled in this study. Only inhouse interpreter services able to be included,

        Exclusion Criteria:

          -  Has clinically significant cognitive impairment or attention disorder preventing
             ability to sit in a chair for 15 minutes

          -  Has confirmed hypertension on previous testing

          -  Parent/caregiver who require an interpreter and cannot upload BP and Heart rate (HR)
             values online independently will be excluded from the study.

          -  Parent/caregiver requiring an interpreter, but the interpreter not present within the
             face-to-face appointment eg, phone interpreter services.
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Gabriel Dabscheck, MBBS FRACP, +61 3 9345 4293, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT05196854

Organization ID

73244


Responsible Party

Sponsor

Study Sponsor

Murdoch Childrens Research Institute


Study Sponsor

Gabriel Dabscheck, MBBS FRACP, Principal Investigator, Murdoch Children's Research Institute


Verification Date

February 2022